Received Aug 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | UNK | — |
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | UNK | — |
Suspected vaccination failure; Shingles/ rash / pain; weakness; could not walk; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, 2 months after receiving Shingles vaccine and an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles/ rash / pain), weakness (Verbatim: weakness) and unable to walk (Verbatim: could not walk). The patient was treated with gabapentin and ferric ammonium citrate, methionine, vitamin b nos (Geritol). The outcome of the vaccination failure, shingles, weakness and unable to walk were not reported. It was unknown if the reporter considered the vaccination failure, shingles, weakness and unable to walk to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles, weakness and unable to walk to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 10-AUG-2025 This case was reported by a patient via interactive digital media. The patient stated they had both injections of Shingles vaccine and two months later had shingles. The rash was minor and gone in a few weeks. The doctor prescribed gabapentin along with another medication, which the patient could not recall. The patient stated they were bedridden for a month, sleeping 10 to 12 hours a day, and experienced very little pain. The patient mentioned it was weakness and could not walk. A friend recommended taking Geritol tablets, which the patient believes have saved him/her. The patient was ashamed about going to Walmart for medication, as people would often ask what had happened to them. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 & 2). US-GSK-US2025AMR104473:Report from same reporter